Feina Activa
es

REGULATORY AFFAIRS (PROJECT MANAGER)

2 Inscrits

Oferta persones amb discapacitat

Referència oferta:

FA06086714

Data publicació oferta:

24/04/2025

Llocs de treball:

1

Consultora de Talento

Descripció de l'oferta

Pharma Industry

BARCELONA - BAIX LLOBREGAT - 08840 VILADECANS

Detall de les funcions del lloc de feina

• Reviewing Marketing Authorization Application (MAA) dossiers and liaising with the RA department at the company’s headquarters in India. • Supporting existing and potential clients with regulatory/technical information about company products. • Preparing and submitting dossiers to health authorities in EU countries using national and decentralized procedures. • Contacting European health authorities to follow up on submissions. • Communicating with European customers to develop RA strategies and coordinate submissions. • Reviewing and submitting response documents to deficiency letters from health authorities. • eCTD publishing. • Ensuring proper maintenance of dossiers, including PSUR submissions, variations, and renewals. • Keeping up to date with the latest regulatory requirements in the region. • Performing selected pharmacovigilance activities. • Providing support for the development of quality agreements and product release. • Proposing, developing, and implementing new standard operating procedures.

Requisits

  • Experiència 3 anys. The profile • valuable education to a degree level in pharmacy or a life science. • 3 to 5 years of experience in the regulatory affairs department of a pharmaceutical company, preferably with generic medicinal products. • experience with european ma procedures (dcps) will be an asset. • experience with procedures in european non-eu countries, such as israel, serbia, and canada, will be an asset. • experience with pharmacovigilance and quality assurance will be an asset. • experience with ectd software will be an asset. • good knowledge of current european regulations on the registration of medicinal products. Knowledge of gmp and pharmacovigilance is a plus. • fluency in english, both written and spoken. Computer skills at a user level.
  • Títol de grau
  • Bachelor's degree in pharmacy or related fields.
  • Anglès (parlat c1 - d.funcional, escrit c1 - d.funcional)

Condicions del lloc de treball

  • Contracte laboral indefinit
  • Jornada completa
  • Salari mensual brut des de '2000' fins a '3000'
  • Altres dades d'interès: flexible working hours